BRIEFING

 Phendimetrazine Tartrate Tablets. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes:

1. Replace the melting point-based Identification A with the retention time agreement as obtained in the Assay.

2. Add Identification B with a UV spectrum agreement as obtained in the Assay and rename Identification B to Identification C accordingly.

3. In the Assay:

   • Revise the Detector to include wavelength range to support the proposed addition of Identification B.

   • Add the particle size for the Column.

   • Add a Tailing factor requirement based on supporting data.

   • Clarify the System Suitability requirements for Resolution and Relative standard deviation.

   • Clarify the definition for R_U and R_S under Analysis.

4. In the Dissolution test:

   • Add the particle size for the Column.

   • Add the calculation equation for the Analysis.

5. Add packaging information and a storage condition to the Packaging and Storage section.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (SM2: F. Gu)

 Case ID—SUB-277